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FDA 510(k)

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

K-Number: K160787 · 2016-08-09

ApplicantSyncro Medical Innovations, Inc.
Decision Date2016-08-09
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is a medical device manufactured by Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2016-08-09 under approval number K160787. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet?

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is a medical device that received FDA 510(k) clearance on 2016-08-09. It is manufactured by Syncro Medical Innovations, Inc.. The 510(k) number is K160787.

When was Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet approved by the FDA?

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet received FDA 510(k) clearance on 2016-08-09, under approval number K160787.

What company makes Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet?

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is manufactured by Syncro Medical Innovations, Inc..

What is the FDA product code for Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet?

The FDA product code for Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet is KNT.

Related Clinical Trials

NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED NCT04035642 Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II) RECRUITING NCT07548281 Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions NOT_YET_RECRUITING NCT05805280 IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease COMPLETED

Other Devices by Syncro Medical Innovations, Inc.

K191784Gabriel Feeding Tube with Balloon, and EnFit Connector K201741Gabriel 3 Way EnFit Valve

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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